Clomipramine hydrochloride - Generic Drug Details

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What are the generic drug sources for clomipramine hydrochloride and what is the scope of patent protection?

Clomipramine hydrochloride is the generic ingredient in two branded drugs marketed by Specgx Llc, Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Aurobindo Pharma, Chartwell Rx, Chemistry Hlth, Jubilant Cadista, Lupin Ltd, Mankind Pharma, Micro Labs, Mylan, Rk Pharma, Sandoz, Taro, Teva, Trupharma, Unique, Watson Labs, and Zydus Pharms, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for clomipramine hydrochloride. Twenty-four suppliers are listed for this compound.

Sponsor	Phase
University of Roma La Sapienza	Phase 3
Fidia Farmaceutici s.p.a.	Phase 4
Assiut University	Phase 3

Sponsor

Phase

University of Roma La Sapienza

Phase 3

Fidia Farmaceutici s.p.a.

Phase 4

Assiut University

Phase 3

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms Co	CLOMIPRAMINE HYDROCHLORIDE	clomipramine hydrochloride	CAPSULE;ORAL	208632-001	Oct 31, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taro	CLOMIPRAMINE HYDROCHLORIDE	clomipramine hydrochloride	CAPSULE;ORAL	074694-001	Dec 31, 1996	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	CLOMIPRAMINE HYDROCHLORIDE	clomipramine hydrochloride	CAPSULE;ORAL	074953-003	Jun 25, 1997	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Trupharma	CLOMIPRAMINE HYDROCHLORIDE	clomipramine hydrochloride	CAPSULE;ORAL	210653-003	Apr 3, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alembic	CLOMIPRAMINE HYDROCHLORIDE	clomipramine hydrochloride	CAPSULE;ORAL	211822-003	Aug 4, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	CLOMIPRAMINE HYDROCHLORIDE	clomipramine hydrochloride	CAPSULE;ORAL	074849-002	Apr 4, 1997		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	0
Tradenames:	2
Applicants:	20
NDAs:	22
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	23
What excipients (inactive ingredients) are in clomipramine hydrochloride?	clomipramine hydrochloride excipients list
DailyMed Link:	clomipramine hydrochloride at DailyMed